Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0065—Inhalators with dosage or measuring devices
  • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0065—Inhalators with dosage or measuring devices
  • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
  • A61M15/007—Mechanical counters
  • A61M15/0071—Mechanical counters having a display or indicator
  • A61M15/0075—Mechanical counters having a display or indicator on a disc
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0065—Inhalators with dosage or measuring devices
  • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
  • A61M15/0081—Locking means
• • G—PHYSICS
  • G06—COMPUTING; CALCULATING OR COUNTING
  • G06M—COUNTING MECHANISMS; COUNTING OF OBJECTS NOT OTHERWISE PROVIDED FOR
  • G06M1/00—Design features of general application
  • G06M1/04—Design features of general application for driving the stage of lowest order
  • G06M1/041—Design features of general application for driving the stage of lowest order for drum-type indicating means
• • G—PHYSICS
  • G06—COMPUTING; CALCULATING OR COUNTING
  • G06M—COUNTING MECHANISMS; COUNTING OF OBJECTS NOT OTHERWISE PROVIDED FOR
  • G06M1/00—Design features of general application
  • G06M1/08—Design features of general application for actuating the drive
  • G06M1/083—Design features of general application for actuating the drive by mechanical means
• • G—PHYSICS
  • G06—COMPUTING; CALCULATING OR COUNTING
  • G06M—COUNTING MECHANISMS; COUNTING OF OBJECTS NOT OTHERWISE PROVIDED FOR
  • G06M1/00—Design features of general application
  • G06M1/14—Design features of general application for transferring a condition from one stage to a higher stage
  • G06M1/16—Design features of general application for transferring a condition from one stage to a higher stage self-operating, e.g. by Geneva mechanism

Definitions

• the present invention relates to
• MDI dispensers and in particular an actuator actuator for ease of use in MDI dispensers.
• Various metered dose aerosol dispensers for inhalation purposes are known which, for example for the treatment of respiratory diseases, dispense an exact dose of medication in the form of a spray or aerosol.
• the reliable dosage of the medication delivered is particularly important, so that a targeted therapeutic effect is brought about in the patient.
• Dosing aerosol devices of this type are, for example, the generally known MDI (metered dose inhalers), which generally have a housing, a container for holding a liquid or powdered medicament, a suitably designed nozzle for atomizing and distributing the medicament and a Have a mouthpiece through which the generated aerosol containing medication is inhaled.
• MDI tered dose inhalers
• the metering aerosol devices are actuated in such a way that the medicament container is displaced in a straight line relative to the nozzle arranged in the housing, as a result of which a defined amount of the atomizing material is released.
• MDI devices are usually designed for multiple doses. It is desirable to indicate to the user the number of doses delivered, in other words, the puffs delivered, or the puffs still available, in order to ensure that the patient is informed at an early stage that the medication has been used up. In this way it is avoided that a patient, for example for the prevention of an acute asthma attack, carries with him an already almost empty metered dose dispenser.
• EP 0 254 391 describes, for example, an inhaler with a flat counter, which is formed on the side of an aerosol dispenser facing the patient. From EP 0 505 321 a reusable inhaler with a resettable counter is known, which is incremented when the storage chamber and the dosing pen reach the first relative position.
• the counter disclosed in GB 1 317 315 has a multiplicity of ring-shaped elements which interact mechanically in order to indicate the doses still available on a display ring. More drug donors with Mechanical counters are disclosed for example in WO 86/02275 and WO 93/24167.
• a metered dose aerosol dispenser with an aerosol container, a nozzle arranged in a nozzle body, via which an aerosol is dispensed when the aerosol container is displaced relative to the nozzle body when the metered dose dispenser is actuated, a counter for counting the actuations of the metered dose dispenser and one
• Actuating device ur switching the counter when actuating the metered dose dispenser, the actuating device being designed and in the Dispensing aerosol dispenser is arranged such that the nozzle body is received inside the actuating device and the nozzle is released for uninfluenced aerosol generation.
• the actuating device advantageously consists of two sleeves which can be displaced relative to one another and which hold the nozzle body of the metering aerosol dispensing device inside.
• the two sleeves of the actuating device are advantageously connected to one another by spring elements which move the sleeves of the actuating device back into an initial position.
• the spring elements are advantageously realized in the form of flat, curved spring elements which are fastened to the outer sides of the sleeves or are formed in one piece.
• guide elements are provided on the sleeves of the actuating device, which ensure a linear displacement of the two sleeves against one another.
• the spring elements can be designed in such a way that they ensure a linear displacement of the two sleeves against one another.
• the actuating device For advancing the counter, the actuating device comprises an actuating arm which acts on the counter.
• the counter In order to implement a counter that is as small as possible, the counter consists of several disk units arranged in parallel, a first disk unit having external teeth has, which cooperates with the actuating device, in particular with the actuating arm.
• the actuating device In order to make the counter and the actuating device into one unit, the actuating device has an opening in which a bearing pin of the counter can be fastened to the actuating device in order to hold the counter.
• the actuating device in particular the lower part, has a recess or an opening through which the nozzle is released.
• Figure 1 is an exploded view of a counter, which cooperates with an actuating device according to the invention for a metered dose dispenser.
• FIG. 2 shows an exploded view of the counter shown in FIG. 1, viewed from the direction of view different from FIG. 1;
• 3 shows a schematic cross-sectional view of a starting or rest position of the second and third disk units to explain the interaction of the second and third disk units
• 4 is a schematic cross-sectional view analogous to FIG. 3, showing the second and third disk units in a position in which the second disk unit is caused by the third disk unit to interact with the fourth disk unit;
• Figure 5 is a separate view of the actuator shown in Figures 1 and 2;
• Fig. 6 shows the arrangement of the invention
• Fig. 7 is an enlarged view of the arrangement of the actuator on the nozzle of a metered dose dispenser.
• Dosage aerosol dispensers described with reference to FIGS. 1 and 2. 1 and 2 each show exploded views of the counter viewed from two different viewing directions.
• the counter essentially has four disk units 1, 2, 3 and 4, which are arranged parallel to one another.
• the center points of the disk units 1, 2, 3 and 4 lie on an axis perpendicular to the disk units and, as will be explained in more detail below, are connected via a bearing pin 8 to an actuating device 10 of a metering aerosol generator (not shown).
• the first, second and fourth disc units 1, 2 and 4 are based on the actuator 10 rotatably arranged.
• the third disk unit 3 assumes a fixed position in relation to the actuating device 10 and thus also to the other disk units.
• the first disc unit 1 has a means for absorbing a force which causes the first disc unit to rotate; this is an external toothing la, into which an actuating arm 5 attached to the actuating device 10 engages (see FIGS. 1 and 2).
• the first disk unit 1 has a smaller radius than the second disk unit 2 and is firmly connected to it.
• the transmission of the rotary movement from the first disk unit 1 to the second disk unit 2 is realized by this fixed connection.
• other means for transmitting the rotary movement and for absorbing the force causing a rotary movement can also be provided on the two disk units.
• a wedge-shaped cam 6 is attached to the outer circumference of the second disk unit 2, which is connected to the second disk unit 2 via a spring element 6a and is referred to below as a spring cam.
• the spring element 6a essentially simulates the outer contour of the second disk unit 2, but has a freely oscillating end.
• the wedge-shaped spring cam 6 is attached to the free-swinging end in such a way that in the rest position it projects beyond the outer contour of the second disk unit 2 in the radial direction.
• the geometry of the spring cam is chosen so that the cam or the nose in a deflection in the radial direction the internal toothing 13 of the fourth disk unit 4 engages.
• the wedge-shaped spring cam 6 is arranged such that the sharp and the blunt edge are oriented perpendicular to the plane of the second disk unit 2.
• the spring cam 6 also has a width that is greater than the thickness of the second disk unit 2, so that the spring cam 6 extends parallel to the axis of the disk units in the manner of a pin in the direction of the third and fourth disk units 3 and 4.
• the spring cam 6 projecting like a pin in the direction of the third and fourth disk unit can interact with a first toothing 13 of the fourth disk unit 4 in interaction with the other elements of the counter, which are explained in more detail in particular with reference to FIGS. 3 and 4 (see FIG . 2).
• the side of the second disk unit 2 pointing in the direction of the third and fourth disk unit has an internal toothing 7 which is arranged symmetrically about the axis of the disk units.
• the internal toothing 7, which can be seen in FIG. 2 but not in FIG. 1, has the same number of teeth as the externally toothed disk unit 1.
• the number of teeth is ten in order to implement a total of 240 discrete counting steps together with a first internal toothing 13 of the fourth disk unit 4 with 24 teeth.
• the radius of the third disk unit 3 is the same or preferably slightly smaller than the radius of the second disk unit 2.
• a wedge-shaped shoulder 11 is attached to the outer periphery of the third disk unit 3, which serves to actuate the spring cam 6 arranged on the second disk unit 2, which will be explained in more detail below. If another shoulder is attached, the gear ratio changes.
• the third disk unit 3 is firmly connected to a bearing pin 8.
• the bearing pin 8 has three different regions with respect to the third disk unit 3, namely the section 8a pointing in the direction of the fourth disk unit 4 and the sections 8b and 8c pointing in the direction of the first and second disk units.
• the diameter of the bearing pin section 8b is identical to that of section 8a, and that of section 8c is reduced in comparison.
• the bearing pin 8 is used for the rotationally fixed attachment of the third disk unit 3 to the actuating device 10 and for the rotatable mounting of the first, second and fourth disk units 1, 2 and 4.
• the bearing pin section with a smaller radius 8c is inserted into a corresponding opening 18 in the fastening unit 10 and attached such that the position of the third disc unit 3 is fixed with respect to the actuator 10.
• the openings provided in the first and second disk units 1 and 2 are matched to the diameter of the bearing pin section 8b such that the first and second disk units 1 and 2 are slidably rotatable on the bearing pin section 8b. It should be noted that the diameters of the sections 8a, 8b and 8c are not limited to the ratio shown in FIGS. 1 and 2, respectively. It is essential that the respective openings the disc units and the diameter of the bearing pin sections are coordinated.
• two L-shaped locking elements 9 are arranged on the bearing pin 8, which are arranged on the outer circumference of the bearing pin section 8b and which engage in the internal toothing 7 of the second disk unit 2.
• the opening of the fourth disk unit 4 is matched to the diameter of the bearing pin section 8a in such a way that the fourth disk unit 4 is slidably rotatable on the bearing pin section 8a.
• two snap hooks 12a which serve to axially fix the disk unit 4, are arranged symmetrically on the section 8a, pointing in the direction of the fourth disk unit 4.
• a locking toothing 12 is attached, which can be seen in FIG. 2.
• the locking teeth 12 consists of four elements which are spaced 90 ° apart.
• the locking teeth can also consist of one or more elements, which are arranged centrally around the axis of the bearing pin 8. This locking toothing 12 engages in a second toothing 14 of the fourth disk unit 4 and essentially serves to secure the rotational position of the disk unit.
• the configuration of the fourth disk unit 4 can be seen in particular from FIG. 1.
• the side of the fourth disk unit 4 pointing in the direction of the other disk units has a first toothing 13, which is arranged on the inner circumference, and a second toothing 14, which is circular around the center of the fourth Disk unit 4 runs.
• the radius of the second toothing 14 is matched to the position of the elements of the locking toothing 12, which is provided on the third disk unit 3.
• the first and second disk units 1 and 2 are arranged on the bearing pin section 8b; the L-shaped locking elements are located here
• the spring cam 6 projects over the outer contour of the third disk unit 3.
• the fourth disk unit 4 is arranged on the bearing pin section 8a and, due to the cap-like shape, receives the third disk unit 3; the spring cam 6 lies between the outer contour of the third disk unit 3 and the first internal toothing of the fourth disk unit 4.
• the first disk unit 1 engages in the external toothing of the first disk unit 1, the first disk unit 1 is rotated in the arrow direction indicated in FIGS. 1 and 2 by a movement of the actuating arm 5.
• the second disk unit 2 also moves, since the first and second disk units 1 and 2 are firmly connected to one another.
• the first and second disk units 1 and 2 slide on the bearing pin section 8b.
• the third disk unit 3 is fixedly connected to the actuating device 10 via the bearing pin 8, so that the position of the third disk unit 3 with respect to the actuating device 10 remains unchanged at all times.
• the spring cam 6 arranged on the second disk unit 2 runs along the outer contour of the third disk unit 3. If one starts from a gearwheel that has ten teeth, the spring cam 6 sweeps over an angle of 360 ° when the arm 5 is actuated 10 times, ie the spring cam makes a full revolution and returns to its starting position. As long as the spring cam 6 is not influenced by the shoulder 11 of the third disk unit 3, the spring cam 6 does not engage in the first toothing 13 attached to the inner circumferential side of the fourth disk unit 4. Only when the shoulder 11 lifts the spring cam 6 in the radial direction does the spring cam 6 engage the first internal toothing of the fourth disk unit 4 and causes the fourth disk unit to rotate about a rotational position.
• FIGS. 3 and 4 show schematic cross-sectional views, which in particular explain the interaction of the second and third disk units 2 and 3 in more detail.
• 3 and 4 the disk units 2 and 3 are shown from the viewing direction shown in FIG. 2.
• the third disk unit 3 is only indicated by dashed lines in both figures for the sake of a better overview. 3 shows the above-mentioned starting position or rest position of the second disk unit 2 in relation to the third disk unit 3 which is firmly connected to the actuating device 10.
• the locking element 9 is latched into the first tooth 7-1 of the internal toothing 7.
• the disk unit 2 is rotated step by step, ie tooth by tooth, in the direction of the arrow indicated in FIG. 3.
• the locking element 9 engages here, starting from the first inner tooth 7-1 in ascending order in the teeth 7-2 to 7-9.
• the spring cam 6 runs along the circumference of the third disk unit 3 shown in broken lines in FIG. 3 without the spring cam 6 being deflected. In this case the spring cam 6 does not engage in the first toothing 13 of the fourth disk unit 4.
• the spring cam 6 in contact with the shoulder 11. This causes the spring cam 6, as shown in Fig. 4, to be deflected in the radial direction. In other words, the spring cam 6 is actuated in this position by the shoulder 11 and the spring cam 6 engages in the inner peripheral toothing 13 and rotates the fourth disk unit 4 by one tooth of the first toothing 13 in the direction of the arrow.
• the second toothing 14 arranged on the inside of the fourth disk unit 4 pointing in the direction of the first, second and third disk unit engages with the latching toothing 12.
• the latching teeth 12 and the second teeth 14 of the fourth disk unit 4 serve to secure the fourth disk unit 4 against rotation, and the snap hooks 12a ensure that the fourth disk unit 4 is axially fixed.
• the second disk unit 2 again assumes the starting position shown in FIG. 3 and the movement of the spring cam 6 described above with reference to FIG. 3 is repeated without the spring cam 6 engaged with the first toothing 13 of the fourth disk unit 4 occurs. Only after the locking element engages again in the tooth 7-10 of the internal toothing 7 is the spring cam 6 deflected again by the shoulder 11, so that it comes into engagement with the internal toothing 13 again and then the fourth disk unit 4 around a tooth of the first internal toothing 13 continues to rotate. In this way, in the case of a 10-tooth first disk unit, the fourth disk unit 4 is rotated by exactly one tooth of the first toothing 13 after 10 actuations of the actuating arm 5.
• the maximum number of counting positions in this case is 240, ie if the fourth disk unit 4 has rotated through 360 °, 240 actuations of the actuating arm 5 have been counted.
• the second toothing 14 of the fourth disk unit 4 has the same number of teeth as the first internal toothing 13.
• the number of teeth of the first and second teeth 13 and 14 can be adapted accordingly to the desired translation.
• a 30-tooth first or second toothing 13 or 14 thus serves to count up to 300 operations.
• the transmission ratio of the counter according to the invention or the number of counts can also be varied by arranging a further shoulder or several shoulders on the outer edge of the third disk unit 3. This enables in particular an uncomplicated and quick adaptation of the counter according to the invention to a desired transmission ratio.
• the fourth disk unit 4 can be designed in the form of a display disk in order to display the counts accordingly. This can be achieved, for example, by printing a pointer or a color marking both on the end face and on the edge of the fourth disk unit 4. In the embodiment shown in Fig. 2, a pointer display element 4a is indicated. The pointer indicates the number of operations in accordance with the rotational position of the fourth disk unit 4.
• actuating device 10 according to the invention is explained in more detail by way of example, which advantageously cooperates with the previously described counter, but possibly also with other counters.
• the actuating device 10 shown in FIGS. 1 and 2 consists of a cylindrical sleeve 15 and a cylindrical lower part 16, which is also a sleeve.
• An actuating arm 5 is attached to the outside of the sleeve 15.
• Sleeve 15 and lower part 16 are connected to one another via an arcuate spring 17.
• suitable guide elements 19, which are attached to the sleeve 15 in the direction of the lower part 16, ensure a linear movement of the sleeve 15 with respect to the lower part 16 .
• the inner circumferential side of the sleeve 15 slides on the outside of the guide elements 19.
• FIG. 6 is an overall view of the arrangement of the actuating device according to the invention and the counter described above in one
• MDI dispenser shown. 6 shows a housing 21 of the metered dose dispenser, which is provided with a mouthpiece 22.
• the mouthpiece 22 is arranged on the lower region of the housing 21 in an angled position.
• a metering aerosol container 23 for receiving an aerosol to be atomized.
• a nozzle area adjoins the lower area of the aerosol container 23 and is inserted into the guide sleeve 15 of the actuating device 10.
• the nozzle itself is not shown in FIG. 6 to clarify the position of the actuating device according to the invention.
• the actuating device 10 is connected to the counter according to the invention, consisting of the disk units 1, 2, 3 and 4, in order to count and display the dispensed or remaining dosages.
• the counter with the actuating device according to the invention can be placed in a conventional manner underneath the aerosol container
• both the sleeve 15 and the lower part 16 of the actuating device 10 have space in the interior for in particular the connecting piece (not visible) of the aerosol container 23 and for the nozzle body of the metering aerosol dispensing device .
• FIG. 7 shows how a cylindrical nozzle body 30 of the metered dose dispenser 21 can be arranged in the sleeve 15 and the lower part 16 of the actuating device 10.
• the cylindrical nozzle body 30 (shown in section), the funnel-shaped nozzle opening 31, a connecting channel 32, which connects the funnel-shaped nozzle opening 31 to a nozzle chamber 33, into which the connecting piece 25 of the aerosol container 23 releases the aerosol in the event of a pump surge.
• the sleeve 15 and the lower part 16 of the actuating device 10 provide sufficient space inside both for the nozzle 30 and for the connection of the aerosol container 23 and since the lower part 16 is designed in such a way that it completely releases the nozzle 31 and the Aerosol generation and - does not affect spreading
• Actuator 10 can be easily arranged on the nozzle body of a given metered dose dispenser, without having to make changes to the nozzle body 30 or the nozzle 31, 32 or the connection 25 for the aerosol container. This means that an approval process going through for the metered-dose aerosol dispensing device is not necessary again, since no modifications to the nozzle design 30, 31, 32, 33 have to be made due to the actuating device 10 according to the invention.
• the release of the nozzle 31 is achieved in that the sleeve forming the lower part 16 has a corresponding recess on the side facing the nozzle, as shown in FIGS. 1, 2, 5, 6 and 7.
• an opening can be provided which is similar to the opening 8, but which is designed such that it releases the nozzle 31.
• a conventional metered dose dispenser does not have to be changed in its essential components, in particular not the nozzle.
• a simple arrangement of an actuating device for actuating the counter in a given device design enables a simple and uncomplicated structure which can be used universally with already known devices. In this way, a complex modification of the already known metered dose dispensers can be dispensed with. This is of great advantage because, for example, in the event of a change the nozzle shape such contents would have to go through medical tests again to obtain approval, which are usually lengthy, time-consuming and therefore costly.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Life Sciences & Earth Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Pulmonology (AREA)
• Hematology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• General Physics & Mathematics (AREA)
• Physics & Mathematics (AREA)
• Theoretical Computer Science (AREA)
• Biophysics (AREA)
• Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
• Mechanical Operated Clutches (AREA)
• Nozzles (AREA)
• Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Level Indicators Using A Float (AREA)
• Medicinal Preparation (AREA)
• Measuring Volume Flow (AREA)
• Spray Control Apparatus (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Lubrication Of Internal Combustion Engines (AREA)

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• 1998
  • 1998-10-08 DE DE19846382A patent/DE19846382C1/de not_active Expired - Fee Related
• 1999
  • 1999-08-24 EP EP99942908A patent/EP1119383B1/fr not_active Expired - Lifetime
  • 1999-08-24 US US09/807,091 patent/US6481438B1/en not_active Expired - Fee Related
  • 1999-08-24 AU AU58545/99A patent/AU5854599A/en not_active Abandoned
  • 1999-08-24 AT AT99946019T patent/ATE243344T1/de not_active IP Right Cessation
  • 1999-08-24 WO PCT/EP1999/006206 patent/WO2000022570A1/fr active IP Right Grant
  • 1999-08-24 AT AT99942908T patent/ATE269733T1/de not_active IP Right Cessation
  • 1999-08-24 US US09/807,104 patent/US6679251B1/en not_active Expired - Fee Related
  • 1999-08-24 DE DE59909822T patent/DE59909822D1/de not_active Expired - Fee Related
  • 1999-08-24 WO PCT/EP1999/006205 patent/WO2000021593A1/fr active IP Right Grant
  • 1999-08-24 DE DE59906035T patent/DE59906035D1/de not_active Expired - Fee Related
  • 1999-08-24 AU AU56243/99A patent/AU5624399A/en not_active Abandoned
  • 1999-08-24 EP EP99946019A patent/EP1119826B1/fr not_active Expired - Lifetime

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